FDA QMSR Implementation Guide: What Medical Device Manufacturers Need to Know

The FDA’s Quality Management System Regulation (QMSR) Final Rule is reshaping how medical device companies approach compliance, quality, and global harmonization. Effective February 2, 2026, QMSR replaces the traditional Quality System Regulation (21 CFR Part 820) and formally incorporates ISO 13485:2016 into U.S. law.

This in-depth whitepaper provides a practical, implementation-focused roadmap to help medical device manufacturers confidently transition to QMSR while maintaining FDA readiness.

What questions does this technical guide answer?

• What is FDA QMSR and how does it differ from QSR (21 CFR Part 820)?
• How does ISO 13485:2016 become legally enforceable under U.S. regulations?
• Which QMS processes, SOPs, and records must be updated for QMSR compliance?
• What FDA-specific requirements remain outside ISO 13485?
• How can an electronic QMS (EQMS) simplify QMSR transition and audits?

What you’ll learn

• Core areas of alignment between QMSR and ISO 13485
• Key terminology, definition changes, and regulatory implications
• Best practices for gap assessments, risk-based QMS updates, and audit readiness
• Ten essential EQMS capabilities that support QMSR compliance

Who should download this guide?

Quality leaders, regulatory affairs professionals, and medical device manufacturers preparing for FDA inspections, ISO audits, or global market expansion.

Download the whitepaper now to accelerate your QMSR readiness and build a future-proof quality system with confidence.